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510(k) Data Aggregation

    K Number
    K213795
    Device Name
    Videa Caries Assist
    Manufacturer
    VideaHealth, Inc
    Date Cleared
    2022-04-21

    (136 days)

    Product Code
    MYN
    Regulation Number
    892.2070
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Videa Caries Assist

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for use by board licensed dentists for the concurrent review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.

    Device Description

    Videa Caries Assist (VCA) software is a cloud-based AI-powered medical device for the automatic detection of carious lesions in dental radiographs. The device itself is available as a service via an API (Application Programming Interface) behind a firewalled network. Provided proper authentication and a bitewing image, the device returns a set of bounding boxes representing the carious lesions detected. VCA is accessed by the dental practitioner through their Dental Viewer. From within the Dental Viewer the user can upload a radiograph to VCA and then review the results. The device outputs a binary indication to identify the presence or absence of findings are present the device outputs the coordinates of the bounding boxes for each finding. If no findings are present the device outputs a clear indication that there are no carious lesions identified.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study details for the Videa Caries Assist device, based on the provided document:

    Acceptance Criteria and Device Performance

    MetricAcceptance Criteria (Implicit)Reported Device Performance (Standalone Study)Reported Device Performance (Reader Study - Aided)Reported Device Performance (Reader Study - Unaided)
    Overall average AFROC FOMImprovement over unaided reads0.740 (95% CI: 0.721, 0.760)0.739 (95% CI: 0.705, 0.773)0.667 (95% CI: 0.633, 0.701)
    Difference in Overall average AFROC FOM (Aided - Unaided)> 0N/A0.072 (95% CI: 0.047, 0.097, p
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